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Document Type: Notice of Intent to Sole Source Solicitation Number: NOI-NIAID-26-0001 Posted Date : 04/13/2026 Response Date: 04/23/2026, 12:00 PM EST Set Aside: N/A NAICS Code: 541714 – RESEARCH AND DEVELOPMENT IN BIOTECHNOLOGY (EXCEPT NANOBIOTECHNOLOGY) Product Service Code: Q301 – MEDICAL – LABORATORY TESTING Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852 Title: Emergent Stability Testing for HIV Adenoviral Vaccine Candidates Description: THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b)(2) and 13.501(a) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive proposals. The National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) intends to negotiate on a sole source basis with Emergent Product Development Gaithersburg Inc. 300 Professional Drive, Gaithersburg, MD 20879 . This acquisition will provide maintenance of the Biologics Master File 018816 – Human Immunodeficiency Virus Type 1, Recombinant (Adenovirus Type 4; Ad4Env150KN and Ad4-Env145FL; 1086 clade C Env; A549 Cells) Vaccines, Live Master File (BB-MF 018816). BB-MF 018816 was originally established by Emergent under Purchase Order 75N93022PO1224 and contains CMC and nonclinical study information for the HIV-1 Adenovirus Type 4-Vectored (A549 cells) Vaccines, Live, Aqueous (Ad4-HIV). Purchase Order 75N93022PO1224 ended with stability work being transitioned to a testing lab contracted by NIAID. While Emergent is no longer directly involved in stability testing, Emergent owns BB-MF 018816, which must remain open and current for NIAID to continue to update IND 030255. NIAID has requested that Emergent maintain BB-MF 018816 throughout the remaining 84, 96, 108, and 120-month stability timepoints. Emergent is the owner of the Biologics Master File 14883 – Manufacture and Characterization of A549 (human lung adenocarcinoma derived) Master Cell Bank, Type II (BB-MF 14883), which concerns the PXVX0329 drug substance, manufactured by inoculating expanded A549 suspension cells with an Ad4-Env150KN viral seed. Emergent's understanding is that BB-MF 14883 must also remain open and current for NIAID to update IND 030255. To maximize collaborative efforts between Emergent, NIAID, and its other contractors, Emergent will assume responsibility for funding the annual report submissions required for BB-MF 14883 in October 2025, October 2026, October 2027, October 2028, and October 2029. Period of Performance: …
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